Kornimate/medical-research-clean huggingface dataset:
a study of humab ox40l in the prevention of allergen-induced airway obstruction in adults with mild allergic asthma

Conditions: Asthma

Summary: this phase ii, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of humab ox40l administered to patients by iv infusion for the treatment of allergen-induced asthma.


Eligibility criteria:
inclusion criteria: * weight between 50 and 125 kg * mild, stable allergic asthma * history of episodic wheeze and shortness of breath * fev1 at baseline ≥ 70% of the predicted value * for women of childbearing potential, agreement to use an effective means of contraception while enrolled in the study * for men with partners of childbearing potential, willingness to use condoms with spermicide during treatment * ability to comprehend and follow all required study procedures * positive skin prick test to common aeroallergens (e.g., cat, dust, mite, grass, and pollen) * positive allergen-induced early and late airway bronchoconstriction exclusion criteria: * a worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry * acute infection (including viral infection) within the 6 weeks preceding dosing (8 weeks for respiratory infections) or any ongoing chronic infection * history of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition, including (but not limited to), tuberculosis, parasitic infection, etc. * lung disease other than mild allergic asthma * history of heart, lung, kidney, liver, neurologic or chronic infectious disease * concomitant disease or condition, which could interfere with the conduct of the study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease * history of serious adverse reaction or hypersensitivity to any drug * pregnancy or lactation or positive serum pregnancy test at screening * chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide * current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months (5 half-lives of the drug), including omalizumab * regular use of tobacco products of any kind or within the previous 6 months, or smoking history \> 10 pack-years

Keywords: anti-ox40l mild allergic asthma allergies allergic asthma adult asthma
safety, tolerability and pharmacokinetics of leo 29102 cream in atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: the purpose of this phase ib study is to investigate the safety, tolerability and pharmacokinetics of leo 29102 2,5 mg/g cream when treating atopic dermatitis (ad) lesions from 10 up to 100% of the body surface area (bsa) twice daily (bid) for 7 days (cohorts i, ii, iii) and from 10% up to 50% of bsa (bid) for 6 weeks (cohort iv). this trial will be performed in four cohorts. cohort i, ii and iii includes patients with a larger bsa that increases from one cohort to the next. after each cohort (cohort i, ii)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated bsa" is justified. cohort iv will start dosing after finalisation of cohort ii and after submission of data from cohort i and ii to the national authority and iec for review.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of ad defined according to hanifin and rajka. 2. investigator global assessment scored as mild (2) to severe (4) ad. 3. at screening, ad lesions amenable for treatment involving 10% to \< 25% (cohort i), 25% to \< 50% (cohort ii), 50% to 100% (cohort iii) and 10% to \< 50% (cohort iv) of the total bsa. 4. on day -1, ad lesions amenable for treatment involving 10% to \< 28% (cohort i), 25% to \< 55% (cohort ii), 50% to 100% (cohort iii) and 10% to \< 55% (cohort iv) of the total bsa. 5. adult male or female subjects, aged 18 to 65 years, inclusive.
integrating a parenting intervention into substance use treatment: a feasibility study

Conditions: Parenting

Summary: while motherhood is central to the design of maternal integrated substance use treatment programs, "evidence-based" parenting interventions tailored to the needs of the population are rare. stakeholder engagement has revealed that the evidence-base is not reflective of the needs of client population. with 34 ecd programs in ontario, ecd programs are unique position to pilot attachment and biobehavioral catch up (abc) and see if it is a good fit for their clients and if it is effective and feasible. abc is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of abc that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.

while motherhood is central to the design of maternal integrated substance use treatment programs, there are few "evidence-based" parenting interventions tailored to the needs of the population. this study will address this limitation in current parenting intervention research by exploring if attachment and biobehavioral catch up (abc) is well suited and feasible to implement within integrated maternal substance use outpatient treatment. abc is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of abc that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.

Eligibility criteria:
inclusion criteria: * women pregnant/parenting children ages 6-24 months * women that are clients of participating ecd agencies exclusion criteria: -
z-360 plus gem in subjects with metastatic pancreatic adenocarcinoma

Conditions: Metastatic Pancreatic Adenocarcinoma

Summary: the primary objective of this study is to compare the efficacy of gem plus z-360 versus gem plus placebo on the overall survival (os) in subjects with metastatic pancreatic adenocarcinoma.


Eligibility criteria:
inclusion criteria: * 1. subjects with histological or cytological evidence of metastatic pancreatic adenocarcinoma, measurable disease or non-measurable disease by response evaluation criteria in solid tumors (recist) version criteria * 2. subjects with a life expectancy of at least 12 weeks, * 3. subjects with an eastern cooperative oncology group performance status (ecog ps) of 0, 1 or 2, * 4. subjects with the following adequate organ functions: * white blood cell count ≥3,000/μl (or absolute neutrophil count ≥1,500/μl) and ≤ 12,000/μl , * platelet count ≥100.0 × 10\^9/l, * hemoglobin ≥9.0 g/dl, * serum creatinine ≤1.5 × the upper limit normal (uln), * total bilirubin ≤2.0 × uln, * serum aspartate transaminase levels ≤3.0 × uln (≤5.0 × uln in presence of liver metastases), and * serum alanine aminotransferase levels ≤3.0 × uln (≤5.0 × uln in presence of liver metastases). exclusion criteria: * subjects received the following previous therapies for pancreatic adenocarcinoma: * surgery within the 4 weeks prior to randomization, * radiation and chemoradiation within the 12 weeks prior to randomization, * radiation for pain relief within the 4 weeks prior to randomization, * gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization, * chemotherapy except gem used as an adjuvant on surgery within the 4 weeks prior to randomization, * gemcitabine ≥600 mg/m\^2 as sensitizer for chemoradiation, * gemcitabine \<600 mg/m\^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization, * gemcitabine used for systemic chemotherapy, or * systemic chemotherapies except gem within the 4 weeks prior to randomization.

Keywords: z-360, pancreatic cancer, pancreatic adenocarcinoma
a study to evaluate molnupiravir (mk-4482; mov) in participants with severe renal impairment (mk-4482-003)

Conditions: Renal Impairment

Summary: this purpose of this study is to evaluate the plasma pharmacokinetics (pk) of n-hydroxycytidine (nhc), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. this study will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and the urinary excretion of nhc after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. the primary hypothesis is that the plasma pk participants with severe renal impairment will be similar to that observed in the healthy mean matched control participants.


Eligibility criteria:
inclusion criteria: the key inclusion criteria include but are not limited to the following: * body mass index (bmi) ≥18.5 kg/m\^2 and ≤35 kg/m\^2 * healthy participants: baseline estimated glomerular filtration rate (egfr) ≥90 ml/min based on the 2021 chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation * severe renal impairment participants: baseline estimated glomerular filtration rate (egfr) \<30 ml/min based on the 2021 ckd-epi creatinine equation exclusion criteria: the key exclusion criteria include but are not limited to the following: * positive for hepatitis b surface antigen (hbsag), hepatitis c antibodies or human immunodeficiency virus (hiv) * history of major surgery, donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy (screening) visit severe renal impairment participants: * history or presence of renal artery stenosis * had a renal transplant * currently taking medications to treat chronic medical conditions associated with renal disease if participant has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of medication(s) within 4 hours prior to and 8 hours after administration of the study drug
efficacy and safety study of new ambroxol hardboiled lozenges in acute pharyngitis

Conditions: Pharyngitis

Summary: primary objective: to assess the efficacy of the new hard boiled ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis. secondary objective: to assess the safety of the new hard boiled ambroxol lozenges 20 mg in patients with acute pharyngitis.

duration per participant is up to 4 days.

Eligibility criteria:
inclusion criteria: * adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to visit 1. * patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale. * signed written informed consent. exclusion criteria: patients suffering from pharyngitis of bacterial origin. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
neuromuscular blockade for post-cardiac arrest care

Conditions: Cardiac Arrest

Summary: the main purpose of this study is to evaluate if neuromuscular blockade improves lactate clearance (and preliminary secondary clinical outcome measures) as compared to usual care in post-cardiac arrest patients undergoing targeted temperature management.

out-of-hospital cardiac arrest (ohca) occurs in more than 300,000 patients in the united states each year with an estimated mortality of greater than 90%. unfortunately, we currently have little to offer in terms of treatment other than supportive care for the post-cardiac arrest patient. neuromuscular blockade (nmb) is sometimes utilized in post-arrest patients particularly for the prevention of shivering. however, usage of nmb remains controversial and current american heart association (aha) recommendations are to minimize utilization. recent prospective randomized trials in patients with acute respiratory distress syndrome suggest a mortality benefit from nmb and an excellent safety profile. furthermore, observational trials in both sepsis and post-cardiac arrest show that the use of nmb is associated with improved survival. given this, we hypothesize that continuous nmb will be beneficial in post-arrest patients. in order to test this hypothesis, we propose a multi-center, randomized, open-label, phase ii trial in post-ca patients comparing sustained nmb administration for 24 hours to standard of care after return of spontaenous circulation (rosc). we will enroll adult, comatose ohca patients with rosc and will utilize an already existing clinical trials network for the completion of the study. patients will be randomized to receive either rocuronium for 24 hours or to receive placebo with usual care. previous data from our group has suggested that lactate levels in the post-arrest patient are a good surrogate marker for mortality. we have therefore chosen to utilize lactate levels at 24 hours as the primary endpoint for the current trial. secondarily we will evaluate clinical endpoints including length of stay (los), in-hospital mortality, and good neurological outcome. we will perform a sub-study of inflammatory markers and oxygen consumption.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) * cardiac arrest with sustained return of spontaneous circulation (rosc) * comatose (i.e., not following commands) following rosc * undergoing targeted temperature management (ttm) * time of enrollment ≤ 6 hours from initiation of targeted temperature management * serum lactate ≥2 exclusion criteria: * pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified rankin scale (mrs) score of 4 or higher) * traumatic etiology of the cardiac arrest * protected population (pregnant, prisoner)

Keywords: cardiac arrest, nmb, neuromuscular blockade, rocuronium
needs assessment tool integrated in clinical practice of head and neck cancer rehabilitation

Conditions: Head and Neck Neoplasms

Summary: the study tests a needs assessment and decision-making tool with patients who are in need of rehabilitation after surgery for head and neck cancer. the purpose is to enhance patient involvement in decision-making.

the study tests a needs assessment and decision-making tool with patients surgically treated for head and neck cancer. the tool will be an integrated part of a new clinical practice with nursing consultations at three seperate time-points in the post-surgical period of the patients. half of the participants will receive nursing consultations using the tool and the other half will receive standard care.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of head and neck cancer * stage t3 or t4 * surgically treated * must be able to speak and understand danish exclusion criteria: * treated surgically for thyroid or parotic cancers * referred to adjuvant radio - or chemotherapy * having an unstable psychiatric illness.
safety and efficacy of uc-mscs in patients with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to investigate the safety and efficacy of umbilical cord derived mesenchymal stem cells (uc-mscs) in patients with moderate to severe psoriasis vulgaris. any adverse events related to uc-mscs infusion will be monitored and the patients will be assessed by psoriasis activity and severity index (pasi) and dermatology life quality index (dlqi) in the baseline and after mscs infusions.

psoriasis is considered as an incurable immune-mediated inflammatory skin disease. the widely used treatments include topical agents, systemic medications and biologic agents, but all of them have some drawbacks or limitations. besides, non-standardized treatment or the disease itself may lead transformation to other diseases, which add more importance to finding improved management strategies. mesenchymal stem cells (mscs) are a heterogeneous population of cells that can differentiate into bone, cartilage and fat cells. they have several functions, such as migration to skin lesions, immunomodulation, limitation of autoimmunity and local paracrine effects. it reported mscs have already been used in some kinds of autoimmune disease, such as systemic lupus erythematosus (sle), systemic sclerosis, crohn disease, rheumatoid arthritis et al. in this study, consenting umbilical cords are donated by healthy donors. after several processing steps, uc-mscs are separated and froze for future infusions. when volunteers are recruited, their condition will be assessed by psoriasis activity and severity index (pasi) and dermatology life quality index (dlqi). then mscs will be infused according to a standard scheme. after all 6 infusions, the patient will be re-assessed by the pasi and dlqi and will be followed up for one year.

Eligibility criteria:
inclusion criteria: * diagnosis of stable psoriasis vulgaris for at least 6 months * baseline psoriasis area and severity index (pasi) score \>= 8 * despite systemic or topical treatment, psoriasis is still in active or recurrent condition * no other psoriasis management (topical or systemic) during the uc-mscs infusions * willing and able to comply with all study requirements and provide informed consent exclusion criteria: * other types of psoriasis, such as pustular psoriasis, psoriatic arthritis * with other disease * systemic treatments within 4 weeks before the baseline visit * topical treatment within 2 weeks before the baseline visit * uncontrolled active infections * evidence of infection with hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) * history of severe systemic disease or malignancy * pregnant or lactating females, or willing to have a baby in the next year * cannot be traced on time * any other situations not suitable for this study determined by the investigators
ibd cancer and serious infection in europe

Conditions: IBD

Summary: the primary objective of i-care is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-tnf alone or in combination with thiopurines among ibd patients. we will stratify the risk of cancers and serious infections according to ibd phenotype and disease activity (clinical, radiologic and endoscopic).

the four main secondary objectives of the i-care project are: * to investigate prospectively the impact of anti-tnf based strategies on the natural history of ibd and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations * to assess the evolution of patient reported outcome (epro) on a yearly basis and the impact of anti-tnf agents on epro in ibd * to evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-tnf therapy for ibd * to assess the healthcare costs and cost-efficacy of current therapeutic strategies in ibd 5-asa and steroids across europe at least 5000 ibd patients treated with 5-asa or steroids and fu for 3 years * use of 5-asa and efficacy (persistence, switch, mucosal healing etc.) * chemoprevention of crc: first study that will specifically and accurately address this question * use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification) * safety of steroids (infections etc) study design: 22 patients per investigator. each investigator will recruit and enrol 20 patients with imposed treatment stratification : group 1: 5 without previous or ongoing exposure to is or biologics, (5 asa and steroids are allowed) group 2: 5 with on-going anti-tnf monotherapy group 3: 5 with thiopurines monotherapy group 4: 5 with on-going combination therapy group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)

Eligibility criteria:
inclusion criteria: * cd or uc * capable to complete ediary on a regular basis, and have access to smartphone or internet * accepted to participate and provide personal information (name, phone and email) for contact * accepted to be contacted by study coordinators on a regular basis for follow up with missing information exclusion criteria: * unable to sign consent * unable to access internet or use smartphone * refused to sign consent or to provide personal identification information

Keywords: lymphoma safety biologic therapies
anticholinergic premedication for sedation with dexmedetomidine during spinal anesthesia

Conditions: Bradycardia

Summary: dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. however, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.

before entering the operation room, patients are randomized in one group (a or c). for sedative premedication, all patients will be injected intramuscularly with midazolam 1mg. after entering the operation room, all patients will be monitored blood pressure, ecg and oxygen saturation. before induction of spinal anesthesia, all patients will be loaded with plasma solution 5ml/kg. after induction of spinal anesthesia, block level will be checked. after fixation of block level, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/ml would be started for 10 minutes. however, just before starting dexmedetomidine,atropine .01\~0.03mg/kg up to 0.5mg would be injected in group a. otherwise normal saline 0.5ml would be injected in group c. the syringed would be blinding not to be noticed. after loading of dexmedetomidine, the diluted solution would be injected with 0.25ug/kg/hr until the end of the surgery. every patients undergoing sedation would be applied the oxygen by nasal prong. the heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously. the number of medication treated would be noted.

Eligibility criteria:
inclusion criteria: * patients who undergoing spinal anesthesia with sedation over 19 years old. exclusion criteria: * patients who are contraindicated of spinal anesthesia such as hypovolemic status, coagulation disorder, infection of tapping site, pregnancy, heart problem, history of drug allergy, drug abuser, anemia, headache and medication of antipsychotic drugs. * patiensts who are contraindicated of atropine such as glaucoma, voiding difficulty due to prostate hyperplasia, heart disease, ulcerative colitis, hyperthyroidism and fever.

Keywords: premedication dexmedetomidine anesthesia, spinal